The development of an innovative drug takes several years and, on average, costs about two billion dollars. The pharmaceutical company that created the new drug owns the rights to it. The patent is valid for up to 25 years. But, after patenting, the drug enters the market only ten or fifteen years later — after all preclinical and clinical trials. It remains about ten years for the manufacturer to make a profit. When protection ends, other companies can make the same drug. But apart from the formula in the patent, they don’t know anything. There is no ready-made composition of original drugs and a scheme for their synthesis in any open source. Tests are carried out on animals and humans. They show the rate of absorption and excretion of the drug from the body, its distribution in tissues and fluids, and the time to reach the maximum concentration in the blood.
Almost 85 percent of drugs sold in the world are generics, that is, copies of original drugs with the same amount of active ingredient and effect on the body. Production technologies in different countries are different, generics are not tested as long and carefully as the originals, so their price is several times cheaper, and their effectiveness raises questions. Most drugs and their generics are sold at Canadian pharmacy generics, a refferal online service to order medicines because prices are regulated by the government and therefore never exceed a certain limit set by the government.
Top 5 Most Anticipated Drug Launches in 2022
Even though it takes years to test new drugs, the biopharmaceutical company and agency Canada are still doing their best to bring new treatments to patients. Now let’s talk about the hottest and potentially most lucrative endorsements in 2022? These drugs will target the most popular diseases and the rarest problems. Treatments range from Alzheimer’s disease and diabetes to psoriasis and lung cancer. Check out the top 5 most anticipated drug launches this year below. As always, let us know what you think of these or any upcoming medications you think we missed.
- Preparation: Bardoxolone
- Company: Reata Pharmaceuticals
- Used for: Chronic Kidney Disease Alport Syndrome Prim
The FDA is to decide the fate of Reata Pharmaceuticals’ chronic kidney disease (CKD) drug bardoxolone on Feb. 25. If approved, it would be the first therapy for patients with Alport syndrome, a disease that damages tiny blood vessels that can lead to kidney disease and kidney failure. While bardoxolone achieved its primary and key secondary targets in a Phase 3 registration trial dubbed CARDINAL, the agency’s panel of experts questioned whether the drug reduced the progression of CKD. The drug has a long history of development. In 2010, Reata closed deals with AbbVie totaling over $800 million. In 2012, a data monitoring committee found that CKD patients in the Phase 3 study had a higher rate of heart-related side effects. In response, Reata suspended the lawsuit, fired half of the staff, and returned to the drawing board. In 2014, Reata moved the drug to an interim study in pulmonary arterial hypertension. In 2017, she began testing in Alport, but two years later, AbbVie withdrew from the contract with the company. Reata paid $75 million to restore rights to its drug, while AbbVie will no longer be entitled to royalties from sales of bardoxolone.
- Drug: Deucravacitinib
- Company: Bristol Myers Squibb
- Used for: Psoriasis
In the case of Deucravacitinib, Bristol Myers Squibb suffered losses, losing to Otezla; This year, industry watchers will begin to see if this bet will pay off. BMS is positioning Deukravacitinib as a potential new oral drug of choice for psoriasis, with potential for expansion in psoriatic arthritis and inflammatory bowel disease. The company predicts peak sales of the drug could exceed $4 billion, while Evaluate Vantage estimated 2026 sales at $2.4 billion in its 2022 preliminary report. Deucravacitinib may be able to shake the status of Otezla’s leader as an oral option, but injectables are a different story. The proportion of patients achieving at least 75% improvement in skin symptoms as measured by the Psoriasis Severity Index in the two Phase 3 BMS trials appeared to be lower than newer injectables such as Novartis’ Cosentyx, Eli Lilly’s Taltz and AbbVie’s Skyrizi achieved in their research. In psoriatic arthritis, the company is conducting two phases 3 trials in moderate to severe disease, and Otezla is back in the spotlight. The first research data is expected in 2024.
- Medication: Gantenerumab
- Company: Roche
- Used for: Alzheimer’s disease Grade
Alzheimer’s disease (AD) is making a comeback after a long hiatus in research. While Eli Lilly ranks first in sales potential with Donanemab, which could generate $6 billion in 2026, Roche is last on the podium with its rival drug gantenerumab. Sales of a drug with a mechanism of action similar to Lilly’s anti-amyloid beta monoclonal antibody are not expected to reach the same level as Donanemab. By 2026, Vantage estimates it will bring in less than half of its $2.5 billion potential competitors. Thus, it remains to be seen whether gantenerumab will be able to gather the clinical data needed to support approval. Genentech is working on many phases 3 studies, and executives including Rachel Doody, MD, Ph.D., global head of neurodegeneration and head of product development franchise, told Fierce Biotech last year that they remain focused on the challenge. rather than on how Biogen’s activities regarding the controversially approved Aduhelm might affect their regulatory prospects.
- Drug: Tirzepatide
- Company: Eli Lilly
- Used for: diabetes
Eli Lilly made our list of the most anticipated drugs this year. Its Alzheimer’s asset Donanemab came in first with estimated sales of $6 billion by 2026, and also came in second with its diabetes prospect Tirzepatide, which Evaluate Vantage estimates could generate $4.9 billion by mid-decade. This is a much firmer market territory for Lilly compared to Alzheimer’s given her long history of diabetes. And like much of his competitive life in this disease, he goes head-to-head with Danish rival Novo Nordisk. Tirzepatide works as a dual GIP and GLP-1 agonist and has been in multiple trials over the past few years to help type 2 diabetic patients reduce blood sugar and weight. The company’s biggest win came last year when it beat Novo Nordisk’s GLP-1 blockbuster, Ozempic, in a head-to-head trial. Data on his fight against obesity will be released in April. At a recent JP Morgan Healthcare conference, Lilly CEO Dave Ricks said the company is mulling the idea of splitting the Tirzepatide brand into diabetes and obesity, as Novo did and selling those pairs separately.
- Medicine: Vutrisiran
- Company: Alnilam
- Used for: Amyloid transthyretin amyloidosis Prim
Vutrisiran is a new Alnylam candidate for the treatment of ATTR Onpattro amyloidosis. The therapy available on the market is given as an infusion every three weeks, making a less burdensome subcutaneous injection of Vutrisiran offered every three months more attractive. The drug formula hits the nerves. The main goal of the drug is to minimize the deposition of protein in tissues. Patients taking Vutrisiran experienced an improvement of 2.2 points, while those in the placebo group worsened by 14.8 points. Vutrisiran also captured key secondary measures, including patient-reported quality of life and a 10-meter walk test.